Recall Z-0767-2017— Firefly Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Firefly Medical, Inc., initiated 2016-11-01, terminated 2017-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: IVEA 500A Intended for Med-Surg patient care.. Reason: The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble..
- Recalling firm
- Firefly Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-01
- Terminated
- 2017-08-01
- Firm location
- Fort Collins, CO, United States
Product description
IVEA 500A Intended for Med-Surg patient care.
Reason for recall
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
Data sourced from openFDA. This site is unofficial and independent of the FDA.